臨床研究等提出・公開システム

Scientific Title	Drug-drug interaction study of Foscenvivint with CYP3A inhibitors in Healthy Male Volnteers (The phase I study).
Public Title	OP-724-003 study

Contact for Scientific Queries	Name	Haruyama Yuushi
	Affiliation	Ohara pharmaceutical Co., Ltd.
	Address	8-1 Akashi-tyo, Chuo-ku, Tokyo
	Telephone	+81-3-6740-7701
	E-mail	chiken@ohara-ch.co.jp
Contact for Public Queries	Name	Department of Clinical Development
	Affiliation	Ohara pharmaceutical Co., Ltd.
	Address	8-1 Akashi-tyo, Chuo-ku, Tokyo
	Telephone	+81-3-6740-7701
	E-mail	chiken@ohara-ch.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 24, 2025
Actual date of first enrollment
Target sample size		6
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1: Healthy Japanese male subjects. 2: Age at the time of obtaining written informed consent is >=18 to <=45 years old. 3: Subjects who are capable of fully understanding the clinical trial and providing written informed consent.
	Exclusion Criteria	1: Subjects with any clinilcal abnormality assessed by the investigator or sub-investigator in laboratory tests, vital signs, or 12-lead ECG in eligibility test. 2: Subjects with a QTcF of >450 msec on a 12-lead ECG in the eligibility test. 3: Subjects who weighs <50.0 kg in the eligibility test.
	Age Minimum	18age old over
	Age Maximum	45age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Healthy volunteers
Intervention(s)		Foscenvivint will be administered single intravenous infusion for 4 hours continuously. Itraconazole will be administered orally once a day repeatedly.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Pharmacokinetics
Secondary Outcome(s)		Safety

Primary Sponsor	OHARA Pharmaceutical Co.,Ltd.

Source of Monetary Support / Secondary Sponsor	AMED(Japan Agency for Medical Research and Development)
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Institutional Review Board, P-One Clinic, Keikokai Medical Corporation
Address	View Tower Hachioji 4F, 8-1, Yokamachi, Hachioji, Tokyo, Japan, Tokyo
Telephone	+81-42-625-5216
E-Mail	irbjimukyoku@keikokai-gr.or.jp
Approval Status	Not approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none